JOB SUMMARY Supervise the activities related with Process Quality and Sterilization area : QA Final, Process Controls oversight and Sterilization / Backend (decanting) activities.
Lead the Process Flow Leader, Quality Control technicians and Direct Labor Operators in charge of the previous mentioned functions.
Accountable for :
Supervise QA Final Operators and Technicians
Supervise Sterilization / Decanting / Backend area and technicians
Monitor Process Performance and escalate issues as required
Provide direction to achieve Company Goals
Develop Personnel (Process Flow Leaders, Technicians and Operators)
Manage the segregation and disposition of non-conforming product
Assure Compliance with Laws and Regulations
Payroll Administration / Kronos
Monitor Procedure vs Practice adherence on the QA Final area
Promote adequate communication with other departments
Provide support on Quality issues identified in the Operations Area
Manage inventory control (Finish Goods, Work In process, Rework material)
Process and / or Equipment qualification / validation
KNOWLEDGE, SKILLS AND ABILITIES
Process Quality in a Medical Device Environment
Basic Statistical knowledge (Control Charts, Standard Deviation, Variation, Process Capability)
Excellent oral / written communications skills
Supervision skills (monitor daily performance, employee evaluations, perform training, assure Quality & Compliance in all activities within the area)
Perform non-conforming events investigations, including CAPA
Understanding, analysis and reporting of Quality Metrics
Ability to work with minimum supervision and take risk-based decisions.
Ability to negotiate with counterparts in order to make business balanced decisions
Provide guidance to assure compliance on Medical Device Regulations
Work on a Production Area Environment
Require to move across the manufacturing room with frequent gowning and de-gowning process
Constant desktop work
Learn measurement techniques on different instruments like (OmniSpec, Optimec JCM, Dokumator)
Required to read high volume of documentation in Computer Monitor or Print information
Available to work on different shifts
Bachelor in Industrial Engineer or related field.
Minimum of 5 years in supervision functions
Minimum of 5 years of experience in the Medical Device or Pharmaceutical industry
Experience in problem solving activities.
Minimum of 3 years of experience in Process Quality Functions
Incoming Inspection experience (preferred)
Preferred CQE or equivalent certification, six sigma, lean process